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Cardiac Sarcoidosis Randomized Trial
NCT03593759 · View on ClinicalTrials.gov ↗
Study Summary
Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).
Conditions Studied
Interventions
- DRUG Methotrexate
- DRUG Prednisone or Prednisolone
Study Locations (20)
Quebec
- Montreal Heart Institute — Montreal
- CIUSSS-Hopital du Sacre-Coeur de Montreal — Montreal
- Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval — Québec
- CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont — Sherbrooke
Ontario
- St. Joseph's Healthcare Centre — Hamilton
- London Health Sciences Centre — London
- University of Ottawa Heart Institute — Ottawa
Connecticut
- Yale-New Haven Hospital — New Haven
Massachusetts
- Tufts Medical Center — Boston
Michigan
- University of Michigan-Michigan Medicine Cardiovascular Center — Ann Arbor
Minnesota
- University of Minnesota — Minneota
New York
- Montefiore Medical Center — New York
Ohio
- The Ohio State University Wexner Medical Center — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2019-01-15 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03593759
The ClinicalTrials.gov registry entry for NCT03593759 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ottawa Heart Institute Research Corporation, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Sarcoidosis appearing as the primary indexed condition, and to 2 interventions — of which Methotrexate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03593759 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Quebec, Ontario, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03593759 about?
NCT03593759 is a clinical study titled "Cardiac Sarcoidosis Randomized Trial". Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low do...
What is the current status of trial NCT03593759?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2019-01-15. Estimated completion is 2025-12.
What conditions does trial NCT03593759 study?
This clinical trial studies the following conditions: Sarcoidosis, Cardiac Sarcoidosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03593759?
The interventions under investigation include: Methotrexate (DRUG), Prednisone or Prednisolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03593759?
This trial is sponsored by Ottawa Heart Institute Research Corporation, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03593759 being conducted?
This trial has 20 study locations across Connecticut, Massachusetts, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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